Recruiting
Phase 2

GK-SRS

Sponsor:

University of Alberta

Code:

NCT06949436

Conditions

Trigeminal Neuralgia (TN)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GK SRS

Study Details

Brief summary:

The goal of this clinical trial is to evaluate Gamma Knife stereotactic radiosurgery (GK-SRS) as an ultra-early treatment option for trigeminal neuralgia (TN).

The main questions it aims to answer are:

1. will earlier GK-SRS provide more durable pain relief compared to later GK-SRS?
2. will earlier GK-SRS reduce or eliminate the need for high-dose medical therapy?
3. will earlier GK-SRS have a lower risk of serious complications compared to other first-line treatments?

If participants are assigned to GK-SRS treatment group, they will be asked to:

• Undergo a preoperative MRI, measurements of heart rate and blood pressure, stereotactic head-frame placement, post-operative management and observation.

Both groups will be asked to:

  • Complete medical histories and neurological examinations. These are part of standard of care.
  • Participants will be asked a series of questions related to overall physical health, pain severity, and mood. Completing these questionnaires is part of the research activity. It will take approximately 15- 30 minutes to complete. These questionnaires include: The Barrow Neurological Institute Pain Intensity Score, Brief Pain Inventory-Facial (BPI-Facial), Visual Analog Scale (VAS), Medication Quantification Scale (MQS), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and the Short Form Health Survey.

Conditions

Trigeminal Neuralgia (TN)

Study ID

NCT06949436

Start date

Jul 30, 2025

Status verified date

Apr, 2026

Completion date

May 1, 2032

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Clinical diagnosis of classical or idiopathic TN, based on clinical history and MRI scan
  • Clinical diagnosis within 2 years prior to enrolment
  • Not deemed medically refractory (defined as adequate pain control despite ≥2 medication trials of adequate dose. Adequate pain control is defined as pain that is considered acceptably controlled by both the patient and treating neurologist, without the need for further dose escalation)
  • If currently on medication, on stable dose x at least 3 months

Exclusion Criteria:

  • Secondary TN
  • Bilateral TN
  • Any contraindications to undergoing GK-SRS
  • Any prior cranial radiation
  • Any prior surgical intervention for TN
  • History of psychiatric diagnoses within 2 years of study participation, or uncontrolled, concurrent psychiatric illness (e.g., depression with recent suicide attempts)
  • Females who are pregnant or breast-feeding

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard arm

Patients allocated to the standard arm will continue their medical management per the judgment of treating physician.

experimental: Gamma Knife stereotactic radiosurgery for TN

Interventions

GK SRS

Under local anaesthesia, a Leksell stereotactic head frame is fixed to the patient's head to allow for complete cranial immobilization during treatment. The retrogasserian (i.e., mid-cisternal) target will be utilized at a single 4 mm isocenter, and 40 Gy will be administered to the 50% isodose line while limiting the brainstem to 12 Gy.

Primary outcome measure

  • Primary outcome measure--pain [ Time Frame: 2 years after the day of GK-SRS treatment, for participants in the Experimental Arm. 2 years after enrolment, for participants in the No-intervention Arm. ]

Central Contacts and Locations

Central contacts

Amanda R Lussoso, BA

lussoso@ualberta.ca

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Tejas Sankar, MDCM PhD

780-407-6869tsankar@ualberta.ca

Amanda R Lussoso, BA

587-532-9085lussoso@ualberta.ca

Principal Investigator:

Tejas Sankar, MDCM PhD

More Information

Sponsor

University of Alberta

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • trigeminal neuralgia
  • Gamma Knife
  • stereotactic radiosurgery
  • surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-04-15.